跳至主要内容
临床试验/NCT02791659
NCT02791659已完成不适用

Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)

Chulalongkorn University0 个研究点目标入组 55 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
主要终点
Effective Radiation Dose

研究概览

简要总结

X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not only the patient, but the personnel of ERCP team may have the effect from the scattered ray. According to the automatic beam adjustment function, the thicker object (eg. lying left lateral) might produce higher scatter ray than thinner object (eg. lying prone). The investigators evaluate the radiation exposure among ERCP personnel compare between patient's 2 different positions.

详细描述

Personal solid-state dosimeters were used to measure the radiation dose on personnel during ERCP procedure. The real-time effective doses were displayed at a monitoring screen. A dosimeter was attached outside thyroid collar of each ERCP team member included of 1st endoscopist, 2nd endoscopist, and nurse anesthetist.

Patients' age, gender, BMI, body thickness, and indications for ERCP were recorded. The patients were randomized into 2 groups by block-of-four. The patients' position was assigned to prone or left lateral decubitus. Each ERCP personnel wore a lead apron and the dosimeter was attached outside the thyroid collar. The ERCP procedure was performed according to the indication in a standard technique. After ERCP procedure, the total fluoroscopic time (minute), fluoroscopy tube voltage (kV), fluoroscopy tube current (mA), patient entrance skin dose (mGy) and personnel effective dose (Sv) from each dosimeter were recorded.

Continuous variables were compared by Student's t-test or Man Whitney U-test, where appropriate. Categorical variables were compared by Chi-square or the Fisher exact test. Statistical analysis was calculated by using SPSS statistical software (version17 for Window, Chicago, USA) and two sided p-value < 0.05 was considered to be statistical significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Indicated for ERCP

排除标准

  • •pregnancy
  • •American Society of Anesthesiologists (ASA) physical status class III - IV
  • •unstable vital signs
  • •patients' position needed to be changed during the procedure
  • •patients who need fixed position for ERCP (such as biliary hilar lesion)
  • •enteroscope-assisted ERCP
  • •the consent form can not be obtained

研究组 & 干预措施

Left lateral decubitus

Active Comparator

In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.

干预措施: Automatic beam adjustment function (Radiation)

Prone

Experimental

In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.

干预措施: Automatic beam adjustment function (Radiation)

结局指标

主要结局

Effective Radiation Dose

时间窗: Immediate after procedure

The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验